Global pharma giant GSK has secured European Commission approval for Exdensur (depemokimab), marking a major milestone for patients with severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). 

 

The drug is cleared for: Add-on maintenance therapy in adults and adolescents (12+) with severe asthma characterized by type 2 inflammation who remain uncontrolled despite high-dose inhaled corticosteroids plus another asthma controller.

 

Also, add-on treatment with intranasal corticosteroids for adults with severe CRSwNP when systemic corticosteroids or surgery fail to provide adequate control.

 

The approval is based on the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen. Each trial met its primary or co-primary endpoints, showing statistically significant and clinically meaningful benefits of adding depemokimab to standard care versus standard care alone.

 

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D at GSK, said: “The approval of Exdensur in the EU means there is now an innovative ultra-long-acting option that offers sustained efficacy over 6 months to protect patients from severe asthma exacerbations and the debilitating symptoms associated with CRSwNP. Exdensur may help redefine care for the millions of patients living with these persistent and burdensome conditions, supporting them in achieving their treatment goals with just two doses a year.”

 

Asthma affects more than 42 million people in Europe, with 5-10% experiencing severe forms that continue to cause exacerbations and reduced quality of life. Patients with CRSwNP also face debilitating daily symptoms, with nearly half remaining uncontrolled. 

 

Exdensur combines high IL-5 binding affinity and potency with an extended half-life, allowing sustained suppression of type 2 inflammation with just two doses per year.

 

Stephanie Korn, Head of the Clinical Research Centre IKF Pneumologie Mainz, said: “People living with the burden of severe asthma face persistent exacerbations driven by uncontrolled type 2 inflammation. A new option with twice-yearly dosing that could provide sustained suppression of type 2 inflammation is a promising innovation for patients in Europe with severe asthma who are in urgent need of novel solutions.”

 

Eugenio De Corso, Professor at University of Perugia, added: “CRSwNP profoundly impacts a patient’s daily life, causing debilitating nasal obstruction which can make breathing, smell, sleeping and other fundamental activities a major challenge. An innovative treatment option like Exdensur, that could help patients achieve their treatment goals in fewer doses, represents an important advance.”